Reason for request

New indication (gastric cancer) and MA amendment (colorectal cancer)

  • Key points

Favourable opinion for reimbursement “as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease and with a PS-ECOG performance score of 0 or 1”.

  • What therapeutic improvement?

No clinical added value in the therapeutic strategy.

  • Role in the care pathway?

In the event of progression of metastatic gastric cancer following first-line chemotherapy (usually a fluoropyrimidine/platinum combination with or without docetaxel as well as HER2-targeted therapy in eligible patients), it has been demonstrated that second-line treatment further prolongs overall survival and improves quality of life. The choice of treatment depends on the previous therapy and the patient’s general condition. European Society for Medical Oncology (ESMO) guidelines recommend the use of the anti-vascular endothelial growth factor monoclonal antibody ramucirumab and/or paclitaxel, irinotecan or docetaxel.

Following the failure of second-line therapies, there are no reference treatments or treatments with a MA. In the ESMO 2016 guidelines, there is no reference treatment; it is indicated that the options not used as second-line therapy may be used sequentially as third-line therapy. Updating of these guidelines has led to the inclusion of trifluridine/tipiracil as  third-line therapy for patients with a PS score of 0–1.

Role of the medicinal product in the care pathway:

LONSURF as monotherapy is a third and later-line treatment for patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction and  a PS-ECOG performance score of 0 or 1.


Clinical Benefit

Moderate

The clinical benefit of LONSURF is moderate in the new MA indication in patients with a PS-ECOG score of 0-1.


Clinical Added Value

no clinical added value

Considering:

  • the low effect size compared to placebo (difference in median overall survival of 2.1 months (HR= 0.69; 95% CI [0.560; 0.855]) and in median progression-free survival of 6 days),
  • the absence of demonstration of an improvement in quality of life,
  • the incidence of grade ≥3 adverse events related to treatment noted in around one in two patients [52.5% vs 13.1%], mainly haematological,

The Committee considers that LONSURF provides no clinical added value (CAV V) for the treatment of patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease and with a PS-ECOG performance score of 0 or 1.


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